scholarly journals Implementing work-related Mental health guidelines in general PRacticE (IMPRovE): a protocol for a hybrid III parallel cluster randomised controlled trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Danielle Mazza ◽  
Samantha Chakraborty ◽  
Vera Camões-Costa ◽  
Justin Kenardy ◽  
Bianca Brijnath ◽  
...  
Keyword(s):  
Mental Health ◽  
General Practice ◽  
Service Use ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Work Outcomes ◽  
Work Related ◽  
Hybrid Iii ◽  
Patient Health ◽  
Randomised Controlled

Abstract Background The Clinical Guideline for the Diagnosis and Management of Work-related Mental Health Conditions in General Practice (the Guideline) was published in 2019. The objective of this trial is to implement the Guideline in general practice. Trial design Implementing work-related Mental health conditions in general PRacticE is a hybrid III, parallel cluster randomised controlled trial undertaken in Australia. Its primary aim is to assess the effectiveness of a complex intervention on the implementation of the Guideline in general practice. Secondary aims are to assess patient health and work outcomes, to evaluate the cost-effectiveness of the trial, and to develop a plan for sustainability. Methods A total of 86 GP clusters will be randomly allocated either to the intervention arm, where they will receive a complex intervention comprising academic detailing, enrolment in a community of practice and resources, or to the control arm, where they will not receive the intervention. GP guideline concordance will be assessed at baseline and 9 months using virtual simulated patient scenarios. Patients who meet the eligibility criteria (>18years, employed, and receiving care from a participating GP for a suspected or confirmed work-related mental health condition) will be invited to complete surveys about their health and work participation and provide access to their health service use data. Data on health service use and work participation compensation claim data will be combined with measures of guideline concordance and patient outcomes to inform an economic evaluation. A realist evaluation will be conducted to inform the development of a plan for sustainability. Results We anticipate that GPs who receive the intervention will have higher guideline concordance than GPs in the control group. We also anticipate that higher concordance will translate to better health and return-to-work outcomes for patients, as well as cost-savings to society. Conclusions The trial builds on a body of work defining the role of GPs in compensable injury, exploring their concerns, and developing evidence-based guidelines to address them. Implementation of these guidelines has the potential to deliver improvements in GP care, patient health, and return-to-work outcomes. Trial registration ACTRN12620001163998, November 2020

scholarly journals Cluster randomised controlled trial of a guided self-help mental health intervention in primary care

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023481 ◽  
Author(s):  
Fiona Mathieson ◽  
James Stanley ◽  
Catherine (Sunny) Collings ◽  
Rachel Tester ◽  
Anthony Dowell
Keyword(s):  
Mental Health ◽  
Primary Care ◽  
General Practice ◽  
Randomised Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Study Results ◽  
Randomised Controlled

ObjectivesTo ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns.Trial designTwo-arm cluster randomised controlled trial.MethodsParticipants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18–65 years, scored ≤35 on the Kessler-10 (K10) and if meeting local mental health access criteria (based on age, low income or ethnic group).Interventions: intervention arm GPs were trained on the UBI approach, with participating patients receiving three structured appointments over 5 weeks. GPs randomised to practice as usual (PAU) did not receive training, and delivered support following their existing practice approaches.Outcome measures: primary outcome was patient-level K10 score at 6 months postrecruitment.Randomisation: GP practices were randomised to UBI training or PAU at the start of the study.Blinding: GPs were not blinded to group assignment.ResultsNumbers randomised: 62 GPs (recruiting 85 patients) were randomised to UBI, and 50 to PAU (recruiting 75 patients).Numbers analysed: 31 GPs recruited at least one patient in the UBI arm (70 patients analysed), and 21 GPs recruited at least one patient in the PAU arm (69 patients analysed).Outcome: K10 scores from an intention-to-treat analysis were similar in UBI and PAU arms, with a wide CI (mean adjusted K10 difference=1.68 points higher in UBI arm, 95% CI −1.18 to 4.55; p=0.255). Secondary outcomes were also similar in the two groups.Conclusions: the UBI intervention did not lead to better outcomes than practice as usual, although the study had lower than planned power due to poor recruitment. The study results can still contribute to the continuing debate about brief psychological therapy options for primary care and their development.Trial registration numberACTRN12613000041752; Pre-results.

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

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